FDA documents obtained under the Freedom of Information Act, revealed that the FDA has been concealing from the medical community and the public serious research misconduct; including fraud, deception, avoidable risks for human subjects — even deaths — that occurred in clinical trials. The FDA documents were obtained by Charles Seife, a journalism professor at New York University, and author of several books about deception.
Key portions in most of the FDA documents were heavily redacted. The missing information includes: the name of the drug studied, the name of the study, and specifically how the misconduct affected the quality / reliability of the data. This made it all but impossible to sort out which study was tainted. Seife and his students examined 600 clinical trials; they were able to identify the drug and pharmaceutical company involved in about 100 cases.
In 2015, Seife published two extremely important articles about FDA concealment of vital medical — one in Slate another in JAMA (the Journal of the American Medical Association). We post excerpts from the Slate article which includes links to the FDA inspectors’ documents; followed by the abstract of the JAMA article.
“Reading the FDA’s inspection files feels almost like watching a highlights reel from a Scientists Gone Wild video. It’s a seemingly endless stream of lurid vignettes—Faked X-ray reports. Forged retinal scans. Phony lab tests. Secretly amputated limbs. All done in the name of science when researchers thought that nobody was watching.
That misconduct happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses.
The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.” ….